Export CDISC SDTM datasets with Define-XML

1. 1

   Open Reports > Data & Exports > Export Data.

2. 2

   Under Choose a report, click CDISC SDTM.

3. 3

   Choose the Site, or all sites.

4. 4

   If you are unblinded and need arms, tick the unblinded option (unblinded exports).

5. 5

   Click Download SDTM Package (ZIP).

   You see "SDTM package exported" with the number of datasets.

• SAS XPT datasets such as DM, SV, DS, AE, MH, CM, EX, DV, IE, VS, EG, PE, LB and QS, with SUPP-- and RELREC where needed, plus the trial summary and visits (TS, TV).
• define.xml (Define-XML 2.1).
• A review report (review/sdtm-export-report.html) and CSV copies for checking.

Each form carries an SDTM domain and each question can carry its own variable, set in the form builder, so the mapping travels with the form. If the export finds items to check, the message points you to the review report. Learn more about CDISC standards.